Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090781
Company: GLENMARK GENERICS
Company: GLENMARK GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/08/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL; 0.125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 211088 | GRAVITI PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | GRAVITI PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 211088 | GRAVITI PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 078894 | ALEMBIC PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 091450 | BRECKENRIDGE PHARM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 211088 | GRAVITI PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 078920 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 020667 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 202633 | AUROBINDO PHARMA LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090781 | GLENMARK GENERICS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 211088 | GRAVITI PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 203855 | SCIEGEN PHARMS INC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 202702 | STRIDES PHARMA |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090865 | TORRENT PHARMS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 207011 | UNICHEM LABS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 090151 | ZENNOVA |
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